Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir

Hepatitis C Genotype 4 Clinical Trial

Official title:

The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03743727
• Other study ID #: LDV SOF T 2018
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2018
• Source: Yassin Abdelghaffar Charity Center for Liver Disease and Research
• Contact: Mamdouh A. Ahmed
• Phone: 02-01221707770
• Email: dr.yassinabdelghaffar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety & efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• HCV chronic infection

• Treatment naive and treatment experienced (previous interferon treatment)

• No cirrhosis or compensated cirrhosis

Exclusion Criteria:

• Co-infection with Hepatitis B (HBV)

• Other associated chronic liver illness

• Patients with history of hematemesis (non-cirrhotic portal hypertension)

• Patients with decompensated cirrhosis (as indicated by biopsy, fibroscan)

• Patients on drugs known to interact unfavorably (Amioidarone, ..)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Genotype 4

Intervention

Drug:
• Combined therapy LDV and SOF
All patients will receive ledipasvir/sofosbuvir fixed dose combination for 12 weeks. Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg). Patients weighing below 35 kg will receive half the adult dose: ledipasvir (45 mg)/sofosbuvir (200 mg).

Locations

Country	Name	City	State
Egypt	Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research	Nasr City	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Yassin Abdelghaffar Charity Center for Liver Disease and Research

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events	The presence of any adverse effects will be used to characterize this outcome measure.	During the 12 weeks of treatment.
Primary	Sustained Viral Clearance	HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.	At Week 12 after end of treatment.